Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
- Conditions
- Premature Birth
- Interventions
- Procedure: Cervical cerclage
- Registration Number
- NCT03251729
- Lead Sponsor
- Thomas Jefferson University
- Brief Summary
The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (\<=25mm) and without prior spontaneous preterm birth
- Detailed Description
Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (\<=25mm) and meeting all other eligibility criteria will be randomized to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous preterm birth \<35 weeks
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 93
- 18 year old or older
- Singleton pregnancy
- No prior SPTB or second trimester losses between 160 and 366 weeks
- TVU CL ≤25mm between 180 and 236 weeks
- Multiple pregnancy
- Prior SPTB or second trimester losses between 160 and 366 weeks
- Cerclage in situ
- Painful regular uterine contraction and/or preterm labor
- Rupture membranes
- Major fetal anomaly or aneuploidy
- Active vaginal bleeding
- Placenta previa and/or accreta
- Cervical dilation >1.0 cm and/or visible membranes by pelvic exam
- Suspicion of chorioamnionitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Vaginal progesterone Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks. Cerclage Cervical cerclage Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks. Cerclage Vaginal progesterone Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
- Primary Outcome Measures
Name Time Method Preterm birth <35 weeks At delivery Incidence of spontaneous preterm birth less than 35 weeks
- Secondary Outcome Measures
Name Time Method Neonatal outcomes: bronchopulmonary dysplasia at least 30 days after delivery, up to 6 months after delivery Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks At delivery Neonatal outcomes: IVH grade 3 or 4 at least 30 days after delivery, up to 6 months after delivery Neonatal outcomes: retinopathy of prematurity at least 30 days after delivery, up to 6 months after delivery Histologically proven clinical chorioamnionitis At delivery Neonatal outcomes: low birth weight (<2500g), At delivery Neonatal outcomes: admission to intensive care nursery At delivery Neonatal outcomes: respiratory distress syndrome at least 30 days after delivery, up to 6 months after delivery Neonatal outcomes: birth weight At delivery Neonatal outcomes: length of neonatal hospital admission at least 30 days after delivery, up to 6 months after delivery Neonatal outcomes: neonatal mortality 28 days after delivery Mean gestational age at delivery At delivery
Trial Locations
- Locations (3)
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University Cattolica del S. Cuore
🇮🇹Rome, Italy
University of Naples Federico II
🇮🇹Naples, Italy